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Axatilimab with Decitabine/Venetoclax for TP53-mutated AML

This study is testing a combination of three drugs: Axatilimab, Decitabine, and Venetoclax, for people with Acute Myeloid Leukemia (AML) that has a specific change in the TP53 gene (TP53-mutated AML). You might be able to join if you have AML with this TP53 mutation or deletion, and you are either newly diagnosed or have had one previous treatment. The researchers want to find the best dose of Axatilimab and see how many people achieve a complete remission without measurable residual disease (MRD-negative complete remission). This study plans to enroll 32 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to determine the best dose level for a later Phase 2 study and will involve about 32 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like the Phase 2 dose level at 1 year and MRD-negative complete remission at 2 months.

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NCT07511062

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Northside Hospital, Inc.
~32 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:DecitabineVenetoclaxAxatilimab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2 Dose Level determination
Measured over 1 year
+1 more outcome measured

Conditions

Acute Myeloid Leukemia
TP53 Gene Mutation

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic SyndromeTP53 Gene

Where it's being run

1 sites across 1 states
Georgia1

Who to contact

Scott R Solomon, MD
[email protected]
404-255-1930
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

MDS/AML or AML with a TP53 mutation or deletion, defined as:
greater than or equal to 10% AND (one of the following):
presence of a TP53 mutation
presence of a TP53 deletion by FISH
positive TP53 staining on IHC of diagnostic bone marrow
Either untreated or first salvage (primary refractory or first relapse)

Exclusion

KPS \<60
active uncontrolled infection
history of HIV or active HBV or HBC infection
currently active second malignancy
calculated CrCl \<40mL/min
AST and/or ALT and/or direct bilirubin \>3x ULN
cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias
history of acute or chronic pancreatitis, history of myositis
known leukemia involvement of CNS
hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant
active acute or chronic GVHD requiring immunosuppressive treatment

What this trial measures

  • Phase 2 Dose Level determination1 year

    To find the recommended phase 2 dose (RP2D) of axatilimab when combined with decitabine and venetoclax by recording adverse events based on the CTCAE v.5.

  • Estimation of MRD-negative complete remission2 months

    To estimate the MRD-negative complete remission rate after 1-2 cycles of induction chemotherapy with decitabine and venetoclax by conducing bone marrow biopsies and disease response assessments after induction